The new European MDR is causing delays and complications for businesses wanting to place a new medical device on the European market. If you're considering placing your device on the U.K. market instead, here's what you need to know for appointing a U.K. responsible person to act on your behalf.
If you're developing an implantable medical device, you need to prove to regulators that it will function safely and effectively 10 years after implantation. However, there is no standard approach to follow, and before setting acceptance criteria, you'll need to find a way to test for leaks. Here is one effective method.
